ProKidney(PROK) - 2025 Q2 - Quarterly Results

Executive Summary Key Highlights of Q2 2025 ProKidney reported significant progress in Q2 2025, including positive topline data from the Phase 2 REGEN-007 study and alignment with the FDA on an accelerated approval pathway for rilparencel using eGFR slope as a surrogate endpoint. The company ended the quarter with strong liquidity, supporting operations into mid-2027 - Achieved FDA alignment on the accelerated approval pathway for rilparencel using eGFR slope as the surrogate endpoint, with topline data anticipated in Q2 2027[3][4][5] - Reported positive topline results from the Phase 2 REGEN-007 study on July 8, 2025, showing a 78% improvement in eGFR slope in Group 1[3][5] - Ended Q2 2025 with $295 million in cash, cash equivalents, and marketable securities, projected to fund operations into mid-2027[5] Regulatory and Clinical Updates FDA Alignment for Accelerated Approval Pathway The FDA confirmed that eGFR slope from the Phase 3 PROACT 1 study can serve as the surrogate endpoint for accelerated approval of rilparencel in patients with type 2 diabetes and advanced CKD. The PROACT 1 study can also support full confirmatory approval, with topline data for accelerated approval expected in Q2 2027 - FDA confirmed eGFR slope as an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with type 2 diabetes and advanced CKD[4][5] - An effect size of at least 1.5 mL/min/1.73m² per year improvement in eGFR slope (versus sham controls) is considered an acceptable demonstration of efficacy[4] - Topline data readout for eGFR slope to support accelerated approval is anticipated in Q2 2027, with more than half of the required patients already enrolled in the Phase 3 PROACT 1 study[5][6] Phase 2 REGEN-007 Positive Topline Results The Phase 2 REGEN-007 study yielded statistically and clinically significant positive topline results, demonstrating a 78% improvement in eGFR slope in Group 1, which replicated the Phase 3 PROACT 1 dosing schedule. The study also showed a favorable safety profile with no rilparencel-related serious adverse events - In Group 1 (n=24), the annual decline in eGFR slope improved by 78%, from -5.8 to -1.3 mL/min/1.73m² after rilparencel treatment, a statistically significant difference (p<0.001)[7] - No rilparencel-related serious adverse events were observed across all 49 patients who received at least one injection, consistent with previous safety profiles[8] - Full results from REGEN-007 will be submitted as a late-breaking clinical trial at the American Society of Nephrology 2025 Kidney Week[5][8] Second Quarter 2025 Financial Highlights Liquidity and Cash Runway ProKidney's cash, cash equivalents, and marketable securities decreased from Q1 2025 but are expected to fund operating expenses and capital expenditures into mid-2027 | Metric | June 30, 2025 (Millions) | March 31, 2025 (Millions) | | :-------------------------------- | :----------------------- | :------------------------ | | Cash, cash equivalents and marketable securities | $294.7 | $328.5 | - Existing cash, cash equivalents, and marketable securities are expected to fund operating expenses and capital expenditures into mid-2027[10] Research and Development Expenses Research and development expenses decreased year-over-year, primarily due to the completion or termination of certain clinical trials, partially offset by increased costs for the ongoing Phase 3 trial and additional R&D personnel | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (Millions) | | :-------------------------- | :----------------- | :----------------- | :---------------- | | Research and development expenses | $25.9 | $29.4 | -$3.5 | - Decrease driven by approximately $7.4 million reduction in clinical study costs from completed/terminated trials, $1.1 million in professional fees, and $0.5 million in equity-based compensation[11] - Offset by increases of approximately $4.3 million for the ongoing Phase 3 trial and $1.5 million in cash compensation due to additional R&D personnel[11] General and Administrative Expenses General and administrative expenses saw a slight increase year-over-year, mainly due to higher cash compensation and operational expenses, partially mitigated by a decrease in equity-based compensation | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (Millions) | | :-------------------------- | :----------------- | :----------------- | :---------------- | | General and administrative expenses | $14.0 | $13.7 | +$0.4 | - Increase primarily driven by approximately $0.8 million in cash compensation and $0.4 million in other operational expenses[13] - Partially offset by a decrease of approximately $0.7 million in equity-based compensation[13] Net Loss and Shares Outstanding The net loss before noncontrolling interest slightly decreased in Q2 2025 compared to the same period in 2024, while the total number of Class A and Class B common stock outstanding increased | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | | :-------------------------------- | :----------------- | :----------------- | | Net loss before noncontrolling interest | $37.0 | $38.5 | - Total Class A and Class B common stock outstanding as of June 30, 2025, was 292,707,888[14] Disease and Company Background About Chronic Kidney Disease Chronic Kidney Disease (CKD) is a progressive condition affecting an estimated 37 million adults in the U.S., with diabetes being its leading cause. ProKidney is developing rilparencel to address the significant unmet need for therapies that can stabilize kidney function in patients with advanced CKD and diabetes - An estimated 37 million adults in the U.S. have CKD, with diabetes being the leading cause[15] - ProKidney is developing rilparencel for 1 to 2 million U.S. patients with Stage 3b/4 CKD and diabetes, a population with high unmet clinical need for therapies that stabilize kidney function[15] About ProKidney Corp. ProKidney is a late clinical-stage cell therapeutics company founded in 2015, focused on chronic kidney disease. Its lead product candidate, rilparencel (REACT®), is a first-in-class, patented, proprietary autologous cellular therapy with RMAT designation, aimed at preserving kidney function in diabetic patients at high risk of kidney failure - ProKidney was founded in 2015 and is a pioneer in treating chronic kidney disease through cellular therapy innovations[19] - Rilparencel (REACT®) is the lead product candidate, a first-in-class, patented, proprietary autologous cellular therapy with RMAT designation[19] - Rilparencel is being evaluated for its potential to preserve kidney function in diabetic patients at high risk of kidney failure[19] Detailed Clinical Trial Information About the Phase 2 REGEN-007 Clinical Trial REGEN-007 was a multi-center, open-label, 1:1 randomized Phase 2 trial designed to assess the safety, efficacy, and durability of up to two rilparencel injections on renal function progression in patients with diabetes and CKD, utilizing two distinct dosing regimens - REGEN-007 was a multi-center Phase 2 open-label 1:1 randomized two-armed trial[16] - Patients had diabetes and CKD with an eGFR of 20-50 mL/min/1.73m²[16] - The study assessed safety, efficacy, and durability of up to two rilparencel injections on renal function progression, with Group 1 replicating the Phase 3 PROACT 1 dosing schedule and Group 2 testing an exploratory, disease progression-triggered regimen[16] About the Phase 3 REGEN-006 (PROACT 1) Clinical Trial PROACT 1 is an ongoing Phase 3, randomized, blinded, sham-controlled study evaluating the safety and efficacy of rilparencel in subjects with advanced CKD and type 2 diabetes. It targets specific eGFR and albuminuria criteria, with eGFR slope as the surrogate endpoint for accelerated approval and a composite endpoint for full approval - PROACT 1 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel[17] - The study focuses on patients with Stage 4 CKD (eGFR 20-30 mL/min/1.73m²) and late Stage 3b CKD (eGFR 30-35 mL/min/1.73m²) with accompanying albuminuria[17] - The surrogate endpoint for accelerated approval is eGFR slope, and the primary composite endpoint includes at least 40% reduction in eGFR, eGFR <15 mL/min/1.73m², dialysis, renal transplant, or renal/cardiovascular death[17][18] Forward-Looking Statements Disclaimer and Risk Factors This section provides a standard disclaimer regarding forward-looking statements, emphasizing that actual results may differ from expectations due to various risks and uncertainties. It lists numerous factors that could impact future performance, including regulatory approvals, clinical trial outcomes, financial stability, and market conditions - The press release includes forward-looking statements, and actual results may differ from expectations due to various factors[20] - Factors that may cause differences include disruptions from domestication, inability to maintain Nasdaq listing, competition, clinical trial results, regulatory requirements, financing challenges, intellectual property rights, and uncertainties inherent in cell therapy R&D[20][21] - The Company cautions readers not to place undue reliance on forward-looking statements and does not undertake any obligation to publicly update or revise them[21] Consolidated Financial Statements Consolidated Balance Sheets The consolidated balance sheets present ProKidney's financial position, detailing assets, liabilities, and stockholders' deficit as of June 30, 2025, and December 31, 2024 | Assets (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $84,940 | $99,120 | | Marketable securities | $209,788 | $259,172 | | Total current assets | $324,440 | $395,884 | | Total assets | $372,133 | $441,073 | | Liabilities and Stockholders' Deficit (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Total current liabilities | $28,262 | $36,217 | | Total liabilities | $32,680 | $39,436 | | Redeemable noncontrolling interest | $1,341,953 | $1,396,591 | | Total stockholders' deficit | $(1,002,500) | $(994,954) | | Total liabilities and stockholders' deficit | $372,133 | $441,073 | Consolidated Statements of Operations The consolidated statements of operations provide a summary of ProKidney's financial performance for the three and six months ended June 30, 2025, and 2024, including revenue, operating expenses, and net loss | Metric (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $221 | $– | $451 | $– | | Research and development | $25,882 | $29,404 | $53,145 | $56,637 | | General and administrative | $14,048 | $13,652 | $28,403 | $26,495 | | Operating loss | $(39,709) | $(43,056) | $(81,097) | $(83,132) | | Interest income | $3,593 | $4,537 | $7,620 | $9,380 | | Net loss before noncontrolling interest | $(36,965) | $(38,466) | $(74,917) | $(73,799) | | Net loss available to Class A common stockholders | $(16,552) | $(12,506) | $(33,286) | $(21,998) | | Basic and diluted EPS | $(0.13) | $(0.16) | $(0.26) | $(0.32) | Consolidated Statements of Cash Flows The consolidated statements of cash flows detail the cash generated from or used in operating, investing, and financing activities for the six months ended June 30, 2025, and 2024, showing the overall change in cash and cash equivalents | Cash Flows (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash flows used in operating activities | $(61,008) | $(72,939) | | Net cash flows provided by investing activities | $46,854 | $86,969 | | Net cash flows (used in) provided by financing activities | $(26) | $139,829 | | Net change in cash and cash equivalents | $(14,180) | $153,859 | | Cash, beginning of period | $99,120 | $60,649 | | Cash, end of period | $84,940 | $214,508 |